Measuring Real-World Effectiveness and Value

Precision therapies are often approved based on small trials, in specialized settings, and using biomarkers as endpoints.  Thus, despite their potential high cost, the evidence of value is lacking which makes real-world evidence crucial. Join Schaeffer Center Director of Research Darius Lakdawalla in discussion with MIT NEWDIGS Director of Research Kay Larholt and Merck Center for Observational and Real-World Evidence Executive Director Megan O’Brien for a discussion about how we should measure and leverage real-world data to assess the value of precision medicines.

This webinar is part of a four-part series on precision medicine. Learn more:

*Funding for this project was made possible in part by 1R13HS026821-01 from the Agency for Healthcare Research and Quality (AHRQ). The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Event Date
Thursday, June 17, 2021
1:00 PM - 1:45 PM Pacific
Participant Bios:

Darius Lakdawalla, PhD, (Moderator) holds the Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at USC, where he sits on the faculties of the USC Schaeffer Center, the USC School of Pharmacy and the USC Price School of Public Policy. He is a widely published, award-winning researcher, and a leading authority in both health economics and health policy.

He is currently a research associate at the National Bureau of Economic Research, associate editor for the American Journal of Health Economics and the Journal of Health Economics. He is also an editorial board member at the American Journal of Managed Care: Evidence-Based Diabetes and the American Journal of Managed Care: Evidence-Based Oncology.

Lakdawalla received his PhD in economics from the University of Chicago and his bachelor’s in mathematics and philosophy from Amherst College. His work has been published in leading journals of economics, medicine and health policy.

Kay M. Larholt, ScD, is Director of Research, NEWDIGS at MIT Center for Biomedical Innovation.  Dr. Larholt is a seasoned statistical professional with 30 years of experience in the Pharmaceutical, Biotechnology, and Medical Device industry.   More recently Dr. Larholt has applied her expertise to the production of real-world evidence using platform strategies to aid in the decision making of down-stream stakeholders – patients, providers and payers.

Dr. Larholt holds a ScD in Biostatistics from Harvard University.

Megan O’Brien, PhD, MPH, is currently an Executive Director within the Global Center for Observational and Real World Evidence at Merck. In this role, Dr. O’Brien leads the Policy Evidence Research team. The focus of this team is to generate evidence to inform policy related discussions around access to pharmaceuticals, and to contribute to real-world evidence, HTA and value framework policies and standards development. In previous roles at Merck, Dr. O’Brien was responsible for the development of economic models for several pharmaceutical products and for value evidence strategies and RWE studies for vaccines. Dr. O’Brien received a PhD in health economics from the Johns Hopkins Bloomberg School of Public health and a Masters Degree in Public Health from Emory University.